Since the introduction of the most severe antibiotic management method (commonly known as 38) in 2011, bacterial resistance has been rapidly becoming a hotspot. National health development planning commission, enacted in 2017, the first antibacterial drug policy documents, namely the general office of the national health and family planning commission on further strengthen the management of clinical application of antibacterial drugs contain bacteria resistant notice (hereinafter referred to as the "notice"), is worth our serious review related just need trend change.
Samples from market data (Shanghai pharmaceutical industry information center, anti-infection drugs market since 2011, slashing, appear after recovery, slow market growth, and in 2013, restored to an all-time high in 2010, continue to grow, every year hit a record high of 25.1 billion yuan in 2016. Compared with 2016, the anti-infection-resistant market remains the first class of cephalosporins, but the absolute value increases and the share decrease is significant. Just need to show anti-infection market is absolutely, and demand diversity presents three characteristics: much complications (especially the fungus flooding after flora disorder), the bacterial drug resistance increased (penicillium carbon alkene, vancomycin and add ring element for growth) and a lot of new treatments. And these three diversification became the main driving force for the growth of anti-infection-resistant drugs in 2011-2016.
Small sales of anti-infective drugs in 2005-2016
There was a general decline in anti-infective drug regulation
As the largest cephalosporin class of anti-infection market, it shows an alternative style. From the sales composition, the number of cephalosporins has declined significantly in the past five years.
The variation of active product regulation in the sample market from 2012 to 2016
In anti-infection drugs, in addition to a handful of small class (idl) increased the number of product gauge or flat, most small class has a different degree reducing, polypeptide, antifungal, anti hepatitis b virus and other lactam class (mainly carbon penicillium alkene) product gauge number were little changed. The average output of the products has risen sharply, but most of them are foreign products. The trend of cephalosporin is obvious to the king, although the total volume is not significantly increased, but the decrease in the quantity of the product is obvious, resulting in an increase in the output of the single product. Other endoamide antibiotics (carbapenems) are closely related to each other because of their proximity to antibacterial profiles.
Strict control of the use of carbapenems
Clinical treatment in recent years due to the rapid development of antibiotics and unreasonable use extensively, the negative effect is hospital infections and drug-resistant strains increase, bacteria resistance, cause the failure of clinical treatment, recurrence of infection, such as increased risk of death.
"Notice" aims to ensure that the best use of antibiotics to resist the development of resistance, the core is the main points of the reinforcement of carbon penicillium alkene special class of antimicrobial agents such as management, in particular is worth to pay close attention to the following points, including:
1) the supply catalogue of antimicrobial agents requires that "the injection formulation of carbapenems should be strictly controlled in the three product regulations";
2) the emphasis on "strengthening on carbon penicillium alkene antimicrobial and add ring element for special use level of antimicrobial agents management", especially for special use level of antimicrobial agents strictly enforce ChuFangQuan restrictions and consultation system, is used in emergencies prescription shall not exceed 1, dosage;
3) emphasized that special use of antibacterial drugs should not be used in the clinic, and that the rate of microbial delivery before the use of special antibacterial agents in the hospital was not less than 80%;
4) antibacterial agents such as carbapenems and special use grade antibacterial agents such as teacycline are used in the first place management: clinical use needs to be reported and collected regularly for analysis.
Can see clearly that in recent years in the field of clinical moderately severe infection with penicillium "last line of defense," said the carbon alkene antimicrobial agents, such as national indications will strictly prescribed examination and approval, use, the drug of the traditional empirical antibiotic therapy will be limited, late of penicillium carbon alkene market movements will be a big impact.
In addition, the more restrictive provisions of the 2017 edition of the health care catalog, which explicitly stipulate that the carbapenems need to be tested for evidence of drug susceptibility. Due to the cost and cycle of drug susceptibility test, it will greatly challenge the existing clinical medicine routine. The growth of carbapenems is unlikely to last.
The amount of the compound cephalospore preparation
So, because of the policy implications, who will fill the market share that the carbon penicilliene class will have?
There is no doubt that the carbapenems are facing market difficulties, and the compound cephalosporins, which are of the same type as beta-lactam, will benefit most from their competition. First, in terms of anti-infection treatment, compound cephalosporin and carbon alkene drugs are broad spectrum antimicrobial agents, especially compound cephalosporin preparations after join beta lactamase inhibitor of enzyme stability and penicillium carbon alkene, in multiple drug-resistant bacteria (MDR) in view of the current common or even superior to the latter, the performance of outstanding performance in terms of percentages of fairly even better, especially in view of the current an increasing incidence of nosocomial infection of engraftment bacterium acinetobacter baumannii, three generations of cephalosporins compound preparations resistant rate of 49%, significantly lower than the carbon penicillium alkene.
In the overall market of cephalospores, the compound growth was slightly faster, the market share expanded significantly, and the cumulative growth of third-generation cephalospore and fourth-generation cephalospore was the largest. Anti-infection drugs from nearly five years the number of active product gauge, despite a few categories have article number rules (such as resistance to AIDS drugs, such as influenza), the other category flat or slightly down (such as cephalosporin, penicillin, etc.).
Mainstream products such as cephalosporin and penicillin showed the trend of the remnant, while the total market share increased slowly while the number of products declined. In the third generation of cephalosporins, the number of products in 2016 decreased by 30.5% compared with 2012. Combined with the increase in sales, the trend of the remnant was becoming more and more obvious. And cefotaxime + shu ba jotham 1.5 g in the mainstream variety in the market about 90% of all samples, is growing rapidly in recent years, the compound growth rate as high as 168.20% in 2012 ~ 2016, become the compound of the fastest growing product in the three generations of cephalosporins, market potential is tremendous.
In 2016, the market share of three generations of cephalosporin products was ranked
(author: guangzhou hanguang medicine) |
